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FDA Product

Amlodipine and Olmesartan Medoxomil

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Amlodipine and Olmesartan Medoxomil

50228-367

Regulatory Information

50228-367

ANDA209010

C73584

December 10, 2018

USA

These highlights do not include all the information needed to use AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS. AMLODIPINE and OLMESARTAN MEDOXOMIL tablets, for oral useInitial U.S. Approval: 2007

Human Prescription Drug Label

1

Company Information

079391286

Active Ingredients

AMLODIPINE BESYLATE

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Class Code: ACTIM

OLMESARTAN MEDOXOMIL

Quantity: 20 mg in 1 1

Code: 6M97XTV3HD

Class Code: ACTIB

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

POLYETHYLENE GLYCOL 3350

Code: G2M7P15E5P

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

Active Moieties

OLMESARTAN

Code: 8W1IQP3U10

AMLODIPINE

Code: 1J444QC288

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